Diabetic Peripheral Neuropathy Type 2NCT07537270
Neural Mobilization vs Cervical Neuromodulation in DPN
A study testing Manual Neural Mobilization and Cervical Neuromodulatory Intervention in people with Diabetic Peripheral Neuropathy Type 2, run by Abeer Abdrabo at 1 site in Egypt.
Trial summary
This study is a three-arm, assessor-blinded, randomized controlled pilot feasibility trial. The primary goal is to evaluate the feasibility and acceptability of conducting a full-scale randomized controlled trial (RCT) comparing two manual therapy techniques: Manual Neural Mobilization (MNM) and Cervical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy Type 2
- What is being tested?
- Manual Neural Mobilization and Cervical Neuromodulatory Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed diabetic peripheral neuropathy
- Ability to attend twice-weekly intervention sessions for 12 weeks
- Stable medication regimen for at least 3 months
Who cannot join
- Severe cardiovascular, neurological, or musculoskeletal disorders
- Recent surgery (<6 months) in lower limbs or cervical spine
- Pregnancy or breastfeeding
- Cognitive impairment preventing informed consent or compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Neural Mobilization Versus Cervical Neuromodulatory Intervention for Glycemic Control in Adults With Diabetic Peripheral Neuropathy: Pilot RCT - Hypothesis-generating Study
This study is a three-arm, assessor-blinded, randomized controlled pilot feasibility trial. The primary goal is to evaluate the feasibility and acceptability of conducting a full-scale randomized controlled trial (RCT) comparing two manual therapy techniques: Manual Neural Mobilization (MNM) and Cervical Neuromodulatory Intervention (CNI) in individuals with Diabetic Peripheral Neuropathy (DPN).
While glycemic control is a central part of managing type 2 diabetes, this study explores whether non-pharmacological manual therapies can serve as adjunctive interventions to improve metabolic outcomes. A total of 75 participants were assigned to either MNM, CNI, or standard care for 12 weeks. The study focuses on recruitment rates, adherence, and safety, while also exploring secondary outcomes like blood glucose levels (HbA1c, FBG) .
Read the detailed description
Background:
Diabetic peripheral neuropathy (DPN) often leads to pain and reduced quality of life. Manual therapy techniques such as Manual Neural Mobilization (MNM) and Cervical Neuromodulatory Intervention (CNI) are typically used for musculoskeletal relief, but their impact on systemic glycemic control in DPN patients is not yet well-established.
Objectives:
To assess the feasibility of the trial protocol (recruitment, retention, and adherence).
To provide preliminary data on the effects of MNM and CNI on glycemic parameters (HbA1c, FBG) and clinical symptoms (pain intensity, functional mobility).
Methodology:
Participants (n=75) with type 2 diabetes and clinically confirmed DPN were randomized into three equal groups:
Group 1 (MNM): Received manual neural mobilization targeting the lower limbs (2 sessions/week for 12 weeks).
Group 2 (CNI): Received cervical neuromodulatory techniques aimed at influencing the autonomic nervous system (2 sessions/week for 12 weeks).
Group 3 (Control): Received standard medical and physiotherapy care.
Outcome Assessment:
Feasibility was measured by tracking recruitment success and participant retention. Secondary exploratory outcomes included laboratory tests for HbA1c and Fasting Blood Glucose, this is a pilot study, the results are intended to inform the design and sample size of future definitive trials rather than to establish final clinical efficacy.
- Conditions
- Diabetic Peripheral Neuropathy Type 2
- Being tested
- Manual Neural Mobilization, Cervical Neuromodulatory Intervention, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Neural MobilizationProcedure or surgery
Manual neural mobilization techniques were applied to improve neural mobility and reduce mechanosensitivity in the lower extremities. Treatment sessions were conducted twice weekly over a 12-week period.
Cervical Neuromodulatory InterventionProcedure or surgery
Cervical neuromodulatory techniques were applied at the cervical spine to modulate neural function and potentially influence systemic outcomes. Sessions were conducted twice weekly for 12 weeks.
Standard CareOther
Participants continued to receive usual care as prescribed, including routine medical management and general physiotherapy advice.
| Study group | Role | What they receive |
|---|---|---|
| Manual Neural Mobilization (MNM) | Experimental | Participants in this group received manual neural mobilization techniques targeting the peripheral nerves of the lower limb. The intervention was administered twice weekly for 12 weeks in addition to standard care. Receives: Procedure: Manual Neural Mobilization |
| Cervical Neuromodulatory Intervention (CNI) | Experimental | Participants in this group received cervical neuromodulatory intervention aimed at influencing neural function via cervical spine techniques. The intervention was delivered twice weekly for 12 weeks in addition to standard care. Receives: Procedure: Cervical Neuromodulatory Intervention |
| Standard Care | Active comparator | Participants in this group received standard medical and physiotherapy care without additional manual therapy interventions over a 12-week period. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Description: The average number of participants recruited per month during the recruitment period.
Measured: 3 months
Retention Rate
Description: The percentage of participants who complete the final assessment at 12 weeks relative to the number of participants randomized.
Measured: 12 weeks
Secondary outcomes (4)
Adherence to Intervention Sessions
Adherence was defined as attending at least 80% of the 24 scheduled sessions over the 12-week intervention period.
Measured: Baseline and 12 weeks
Fasting blood glucose level
FBG will be measured using venous blood samples to assess metabolic control
Measured: Baseline, Week 6, and 12 weeks
Random Blood Glucose (RBG)
RBG will be measured using venous blood samples to assess metabolic control.
Measured: Baseline, Week 6, and 12 weeks
Glycated Hemoglobin (HbA1c)
HbA1c will be measured using venous blood samples, reflecting average blood glucose over approximately 3 months.
Measured: Baseline : 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start5 Feb 2026
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abeer Abdrabo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abeer Abdrabo, Isra University, Jordan
- Investigators
- abeer abdrabo, Principal investigator, Isra University, JordanAmira Ezzat, Principal investigator, Heliopolis University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537270
- Sponsor's protocol ID
- DPN-MNM-CNI-2026-01
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the associated publication will be shared with researchers who provide a methodologically sound proposal, for the purpose of achieving the aims in that proposal.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Neural Mobilization Versus Cervical Neuromodulatory Intervention for Glycemic Control in Adults With Diabetic Peripheral Neuropathy: Pilot RCT - Hypothesis-generating Study
- ClinicalTrials.gov ID
- NCT07537270
- Acronym / sponsor ID
- DPN-MNM-CNI-2026-01
- Conditions
- Diabetic Peripheral Neuropathy Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Abeer AbdraboUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a three-arm, assessor-blinded, randomized controlled pilot feasibility trial. The primary goal is to evaluate the feasibility and acceptability of conducting a full-scale randomized controlled trial (RCT) comparing two manual therapy techniques: Manual Neural Mobilization (MNM) and Cervical Neuromodulatory Intervention (CNI) in individuals with Diabetic Peripheral Neuropathy (DPN).
While glycemic control is a central part of managing type 2 diabetes, this study explores whether non-pharmacological manual therapies can serve as adjunctive interventions to improve metabolic outcomes. A total of 75 participants were assigned to either MNM, CNI, or standard care for 12 weeks. The study focuses on recruitment rates, adherence, and safety, while also exploring secondary outcomes like blood glucose levels (HbA1c, FBG) .
Detailed description
Background:
Diabetic peripheral neuropathy (DPN) often leads to pain and reduced quality of life. Manual therapy techniques such as Manual Neural Mobilization (MNM) and Cervical Neuromodulatory Intervention (CNI) are typically used for musculoskeletal relief, but their impact on systemic glycemic control in DPN patients is not yet well-established.
Objectives:
To assess the feasibility of the trial protocol (recruitment, retention, and adherence).
To provide preliminary data on the effects of MNM and CNI on glycemic parameters (HbA1c, FBG) and clinical symptoms (pain intensity, functional mobility).
Methodology:
Participants (n=75) with type 2 diabetes and clinically confirmed DPN were randomized into three equal groups:
Group 1 (MNM): Received manual neural mobilization targeting the lower limbs (2 sessions/week for 12 weeks).
Group 2 (CNI): Received cervical neuromodulatory techniques aimed at influencing the autonomic nervous system (2 sessions/week for 12 weeks).
Group 3 (Control): Received standard medical and physiotherapy care.
Outcome Assessment:
Feasibility was measured by tracking recruitment success and participant retention. Secondary exploratory outcomes included laboratory tests for HbA1c and Fasting Blood Glucose, this is a pilot study, the results are intended to inform the design and sample size of future definitive trials rather than to establish final clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Neural Mobilization (MNM) | Experimental | Procedure: Manual Neural MobilizationParticipants in this group received manual neural mobilization techniques targeting the peripheral nerves of the lower limb. The intervention was administered twice weekly for 12 weeks in addition to standard care. |
| Cervical Neuromodulatory Intervention (CNI) | Experimental | Procedure: Cervical Neuromodulatory InterventionParticipants in this group received cervical neuromodulatory intervention aimed at influencing neural function via cervical spine techniques. The intervention was delivered twice weekly for 12 weeks in addition to standard care. |
| Standard Care | Active comparator | Other: Standard CareParticipants in this group received standard medical and physiotherapy care without additional manual therapy interventions over a 12-week period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically confirmed diabetic peripheral neuropathy
- Ability to attend twice-weekly intervention sessions for 12 weeks
- Stable medication regimen for at least 3 months
Key exclusion criteria (4 listed)
- Severe cardiovascular, neurological, or musculoskeletal disorders
- Recent surgery (<6 months) in lower limbs or cervical spine
- Pregnancy or breastfeeding
- Cognitive impairment preventing informed consent or compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Neural MobilizationManual neural mobilization techniques were applied to improve neural mobility and reduce mechanosensitivity in the lower extremities. Treatment sessions were conducted twice weekly over a 12-week period. | Procedure or surgery | Manual Neural Mobilization (MNM) |
| Cervical Neuromodulatory InterventionCervical neuromodulatory techniques were applied at the cervical spine to modulate neural function and potentially influence systemic outcomes. Sessions were conducted twice weekly for 12 weeks. | Procedure or surgery | Cervical Neuromodulatory Intervention (CNI) |
| Standard CareParticipants continued to receive usual care as prescribed, including routine medical management and general physiotherapy advice. | Other | Standard Care |
Primary outcome
Recruitment Rate
Time frame: 3 months
Description: The average number of participants recruited per month during the recruitment period.
Retention Rate
Time frame: 12 weeks
Description: The percentage of participants who complete the final assessment at 12 weeks relative to the number of participants randomized.
4 secondary outcomes
Adherence to Intervention Sessions
Time frame: Baseline and 12 weeks
Fasting blood glucose level
Time frame: Baseline, Week 6, and 12 weeks
Random Blood Glucose (RBG)
Time frame: Baseline, Week 6, and 12 weeks
Glycated Hemoglobin (HbA1c)
Time frame: Baseline : 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the associated publication will be shared with researchers who provide a methodologically sound proposal, for the purpose of achieving the aims in that proposal.
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Neuropathic Pain and Type II Diabetic Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abeer abdrabo principal investigator
Isra University, Jordan
Amira Ezzat principal investigator
Heliopolis University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Neural Mobilization and Cervical Neuromodulatory Intervention in people with Diabetic Peripheral Neuropathy Type 2, run by Abeer Abdrabo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.